<![CDATA[FDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AML]]>

Advertisement News|Articles|May 13, 2026 FDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AML Author(s)Kristi Rosa Fact checked by: Courtney Flaherty Key Takeaways Approval targets older/unfit newly diagnosed AML, introducing an all-oral HMA/venetoclax backbone that may reduce infusion burden and expand outpatient feasibility. ASCERTAIN‑V part B delivered DEC‑C days 1–5 q28d with venetoclax ramp-up to 400 mg then 400 mg daily through day 28 for cycles 1–3. Efficacy signals included CR 46.5%, CR/CRi 63.4%, 12‑month response maintenance 75.3% among CRs, and median OS 15.5 months at 11.2‑month follow-up. Enrolled population reflected frail biology and heterogeneity: median age 78, ECOG 1 in 51.5%, ELN favorable/intermediate/adverse 31.7%/33.7%/29.7%, and TP53 mutations in 16.8%. Toxicity was dominated by cytopenias and febrile neutropenia; grade ≥3 AEs occurred in 98.0%, interruptions in 68.3%, discontinuations in 8.9%, and fatal AEs in 15.8%.SHOW MORE The FDA has approved oral decitabine/cedazuridine plus venetoclax for newly diagnosed AML unfit for intensive chemo, based on phase 2 ASCERTAIN-V data. Advertisement The FDA has approved decitabine and cedazuridine (Inqovi) in combination with venetoclax (Venclexta) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are at least 75 years of age or who have comorbidities that preclude the use of intensive induction chemotherapy.1The regulatory decision is supported by findings from the phase 2 ASCERTAIN-V study (NCT04657081), which showed that patients treated with the combination achieved a complete response (CR) rate of 41.6% (95% CI, 31.9%-51.8%) with a median time to CR of 2 months (range, 0.4-15.3 months). The median duration of CR was not reached (range, 0.5-16.3 months).Additional results from ASCERTAIN-V were shared during the 2025 ASCO Annual Meeting2 and the 2025 EHA Congress.3 At a median follow-up of 11.2 months, the regimen elicited a complete response (CR) rate of 46.5% (95% CI, 36.5%-56.7%);2 the CR/CR with incomplete hematologic recovery rate was 63.4% (95% CI, 53.2%-72.7%) and the CR/CR with partial hematologic recovery rate was 51.5% (95% CI, 41.3%-61.6%). The median time to CR was 2.4 months. Of those who achieved a CR, 80.0% continued to respond for 6 months, and 75.3% continued to respond for 12 months. The median overall survival with the combination was 15.5 months (95% CI, 7.6-not estimable).What is the design of ASCERTAIN-V trial examining decitabine/cedazuridine plus venetoclax in AML?For phase 2 part B of the trial, decitabine and cedazuridine were administered on days 1 to 5 of every 28-day treatment cycle.2 In cycle 1, venetoclax was given at a ramp-up dose of 100 mg on day 1, 200 mg on day 2, 400 mg on days 3 to 5, and 400 mg on days 6 to 28. For cycles 2 and 3, decitabine and cedazuridine continued to be given on days 1 to 5. Venetoclax was given at a dose of 400 mg for days 1 to 28. Treatment continued until disease progression, unacceptable toxicity, or study withdrawal.The median patient age was 78 years (range, 63-88), with 81.2% aged 75 years or older. Most patients were male (60.4%), and approximately half (51.5%) had an ECOG performance status of 1. In terms of cytogenetic risk, which was classified per European Leukemia Net 2017 criteria, patients had favorable-risk disease (31.7%), intermediate-risk disease (33.7%), or adverse-risk disease (29.7%). Moreover, 16.8% of patients had tumors with TP53 mutations.What was the safety profile of decitabine/cedazuridine plus venetoclax in this population of patients with AML?Any adverse effects (AEs) occurred in 99.0% of patients (n = 101), with 80.2% being related to treatment. Serious toxicities were reported in 84.2% of patients, with 35.6% related to treatment. Grade 3 or higher AEs were experienced by 98.0% of patients; 72.3% of these effects were related to treatment. The most common TRAEs reported with the regimen were anemia (all grade, 32.7%; grade ≥ 3, 29.7%), decreased platelet count (26.7%; 24.8%), neutropenia (25.7%; 25.7%), febrile neutropenia (24.8%; 24.8%), thrombocytopenia (21.8%; 19.8%), decreased neutrophil count (20.8%; 19.8%), nausea (19.8%; 0%), decreased appetite (17.8%; 1.0%), and decreased white blood cell count (14.9%; 14.9%).AEs resulted in dose reduction or treatment interruption for 13.9% and 68.3% of patients, respectively. Moreover, AEs led to treatment discontinuation for 8.9% of patients; AEs proved to be fatal for 15.8% of patients.What is the significance of the approval?In a recent Rapid Readouts program4 on ASCERTAIN-V, Amer Zeidan, MBBS, of Yale School of Medicine, in New Haven, Connecticut, said: “In newly diagnosed patients with AML ineligible for intensive chemotherapy, the all-oral regimen of decitabine/cedazuridine plus venetoclax represents a potential new standard of care.”Check out the video below for additional expert insights about the significance of this approval from Courtney D. DiNardo, MD, MSCE, of The University of Texas MD Anderson Cancer Center in Houston. ReferencesTaiho Oncology and Taiho Pharmaceutical announce U.S. FDA acceptance of supplemental new drug application for Inqovi in combination with venetoclax to treat patients with acute myeloid leukemia. News release. Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd. July 9, 2025. Accessed February 23, 2026. https://www.taihooncology.com/us/news/taiho-oncology-and-taiho-pharmaceutical-announce-us-fda-acceptance-of-supplemental-new-drug-application-for-inqovi-in-combination-with-venetoclax-to-treat-patients-with-acute-myeloid-leukemia/Zeidan AM, Griffiths EA, Dinardo CD, et al. An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: results from a phase 2 cohort of 101 pts. J Clin Oncol. 2025;43(suppl 16):6504. doi:10.1200/JCO.2025.43.16_suppl.6504Roboz G, Zeidan AM, Mannis G, et al. All-oral decitabine-cedazuridine (Dec-C) + venetoclax (Cen) in patients with newly diagnosed acute myeloid leukemia (AML) ineligible for induction chemotherapy: phase 1/2 clinical trial results. Presented at: 2025 European Hematology Association Congress; June 12-15, 2025; Milan, Italy. Abstract S135.Zeidan A. An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients with newly diagnosed AML ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 patients. OncLive.com. June 19, 2025. Accessed February 23, 2026. https://www.onclive.com/view/6504---an-all-oral-regimen-of-decitabine-cedazuridine-dec-c-plus-venetoclax-ven-in-patients-with-newly-diagnosed-aml-ineligible-for-intensive-induction-chemotherapy-results-from-a-phase-2-cohort-of-101-pts- NewsletterStay up to date on the most recent and practice-changing oncology dataSubscribe Now! Advertisement Related ContentAdvertisementFDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell LymphomaByChris RyanMay 13th 2026Dr Dinardo on the FDA Approval of Decitabine/Cedazuridine Plus Venetoclax in AMLByCourtney DiNardo, MD, MSCEMay 13th 2026Tirabrutinib and CAR T-Cell Therapy Represent Potential Paradigm Shifts in R/R PCNSL ByRiley KandelMay 13th 2026Consensus Recommendations Address Key Controversies in Lymphoma ManagementByChris RyanMay 13th 2026UCSF Receives Major Gift to Advance Research and ModernizationByUCSF HealthMay 13th 2026 Latest CMEMultimediaCommunity Practice Connections™: Empowering Interventional Radiologists in the Emerging Era of Oncolytic Immunotherapies for MelanomaYana G. Najjar, MD; Douglas B. Johnson, MD, MSCI; Rahul A. Sheth, MD, FSIR View moreVideoCommunity Oncology Connections™: Beyond Primary End Points – Digging Into Randomized and Real-World Data to Guide Challenging Treatment Decisions in HR+/HER2− Metastatic Breast Cancer | Empire State Hematology & Oncology SocietySeth A. Wander, MD, PhD; Girish Kunapareddy, MDView moreVirtual EventArkansas Association of Cancer Professionals2 Sessions are Available!View moreVideoCommunity Oncology Connections™: Beyond Primary End Points – Digging Into Randomized and Real-World Data to Guide Challenging Treatment Decisions in HR+/HER2− Metastatic Breast Cancer | South Carolina Oncology SocietySeth A. Wander, MD, PhD; Kit Lu, MDView moreVideo19th Annual New York GU Cancers Congress®Maha Hussain, MD, FACP, FASCO; Daniel P. Petrylak, MDView moreIn-Person + Virtual EventGo to PER in ChicagoMay 29-31, 2026View moreVideoCommunity Oncology Connections™: Beyond Primary End Points – Digging Into Randomized and Real-World Data to Guide Challenging Treatment Decisions in HR+/HER2− Metastatic Breast Cancer | Tennessee Oncology Practice SocietySeth A. Wander, MD, PhD; Kamel Abou Hussein, MDView moreVirtual EventIowa Oncology Society1 Session is Available!View moreVirtual EventKansas Society of Clinical Oncology1 Session is Available!View moreVideoA Case-Guided Discussion on Managing Immune Thrombocytopenic Purpura (ITP)Cindy Neunert, MD, MSCS; Hanny Al-Samkari, MD; Joseph Shatzel, MD, MCRView moreVirtual EventLouisiana Oncology Society1 Session is Available!View moreVirtual EventMissouri Oncology Society1 Session is Available!View moreVirtual EventNew Mexico Society of Clinical Oncology1 Session is Available!View moreVideoTumor Board: Expert Insights on Managing Classical 𝘌𝘎𝘍𝘙 Mutations, 𝘌𝘎𝘍𝘙 Exon 20 Insertions, and Atypical 𝘌𝘎𝘍𝘙 Mutations in Metastatic NSCLCBalazs Halmos, MD, MS; Enriqueta Felip, MD, PhD; Julia Rotow, MDView moreVideoCases & Conversations™: Transforming AML Care—Precision Strategies, Evolving Therapies, and Clinical InsightsGail J. Roboz, MD; Hagop Kantarjian, MD; Catherine Lai, MD, MPH; Amer Zeidan, MBBS, MHSView moreVideoMedical Crossfire®: Integrating Next-Generation Endocrine Targeting Therapies to Improve Outcomes for Patients With HR+/HER2- Breast CancerWilliam J. Gradishar, MD, FASCO, FACP; Laura Huppert, MD; Yuan Yuan, MD, PhDView moreVideoMedical Crossfire®: Improving Patient Outcomes in Myeloproliferative Neoplasms With Novel Therapeutic ApproachesRami Komrokji, MD; Gabriela Hobbs, MD; John Mascarenhas, MD; Naveen Pemmaraju, MDView moreVideoMedical Crossfire®: Precision Medicine in Glioma Treatment — Integration of Molecular Profiling to Inform Targeted TherapiesVinay K. Puduvalli, MD; Manmeet Ahluwalia, MD, MBA; Stephen J. Bagley, MD, MSCE; Angela Waanders, MD, MPH, MSView moreVideoMedical Crossfire®: Harnessing the Power of Modern Therapies in Newly Diagnosed Multiple MyelomaC. Ola Landgren, MD, PhD; Mohamad Mohty, MD, PhD; Surbhi Sidana, MDView moreVideoMedical Crossfire®: Expert Perspectives on Targeting c-Met Overexpression and 𝘔𝘌𝘛 Genomic Alterations in NSCLC – Unveiling the Complexities of 𝘔𝘌𝘛 DysregulationRebecca Heist, MD, MPH; Alex A. Adjei, MD, PhD, FACP; Sandip Patel, MD, FASCO; Jeremy Segal, MD, PhDView moreVideoEvolving Treatment Strategies in Pancreatic Cancer: Current Standards, Emerging Targets, and the Role of Molecular TestingEileen M. O’Reilly, MD; E. Gabriela Chiorean, MD, FASCO; Michael J. Pishvaian, MD, PhD; Brian Wolpin, MD, MPHView moreVideoGI Tumor Board—Applying Recent Advances in Biomarker Testing and Treatment in Metastatic Colorectal CancerJohn H. Strickler, MD; Stacey A. Cohen, MD; Aparna Parikh, MD; Kanwal P.S. Raghav, MBBS, MDView moreVideoCases and Conversations™: Sorting Through the Expanding Treatment Options for Patients with Relapsed/Refractory Multiple MyelomaC. Ola Landgren, MD, PhD; Mohamad Mohty, MD, PhD; Surbhi Sidana, MDView moreVideoPER Tumor Board®: Applying Recent Advances to Transform the Treatment Paradigm in SCLC—Expert Perspectives on New Approvals and Emerging StrategiesJonathan W. Goldman, MD; Percy Lee, MD, FASTRO; Erminia Massarelli, MD, PhD, MS; Misty D. Shields, MD, PhDView moreVideoBreast Cancer Tumor Board: Targeting TROP2 – Innovations in Triple-Negative Breast Cancer TreatmentJoyce O’Shaughnessy, MD; Matthew P. Goetz, MD; Hope S. Rugo, MD, FASCOView moreMultimediaEstablishing the Rationale for ADC and ICI Combinations in TNBCVirginia Kaklamani, MD, DSc; Tiffany A. Traina, MD, FASCOView moreMultimediaBreaking Down the Rationale for Targeting TROP2 in TNBCFilipa Lynce, MD; Rita Nanda, MDView moreMultimediaDissecting Clinical Trial and Real-World Data for ADCs in TNBCFilipa Lynce, MD; Rita Nanda, MDView moreMultimediaEvaluating the Latest Data and Ongoing Trials for Novel ADC Approaches in TNBCAditya Bardia, MD, MPH, FASCO; Erika P. Hamilton, MDView moreMultimediaExpert Guidance on Frequently Asked Questions Regarding the Use of ADCs in TNBCAditya Bardia, MD, MPH, FASCO; Erika P. Hamilton, MD; Virginia Kaklamani, MD, DScView moreAudioBreaking Down the Latest Clinical Data for First-line Maintenance and R/R SCLCRahul Gosain, MD, MBA; Rohit Gosain, MD; Hossein Borghaei, DO, MSView moreVideoCross-Disease Integration of Immunotherapy InnovationsGhassan Abou-Alfa, MD, MBA; Laura Williams Goff, MD, MSCI, MMHC, FASCO; Arndt Vogel, MD, PhDView moreVideoOptimizing Treatment for Biliary Tract CancersGhassan Abou-Alfa, MD, MBA; Laura Williams Goff, MD, MSCI, MMHC, FASCO; Arndt Vogel, MD, PhDView moreVideoBroadening the Frontline—Studies Informing the Use of Immunotherapy in Hepatocellular CarcinomaGhassan Abou-Alfa, MD, MBA; Laura Williams Goff, MD, MSCI, MMHC, FASCO; Arndt Vogel, MD, PhDView moreMultimediaPER Resource Center: Integrating Novel Approaches in TNBC – New Avenues for TROP2-Targeting ADCs and Beyond – NursingAditya Bardia, MD, MPH, FASCO; Erika P. Hamilton, MD; Virginia Kaklamani, MD, DSc; Filipa Lynce, MD; Rita Nanda, MD; Tiffany A. Traina, MD, FASCOView moreVideoShow Me the Data®: New and Emerging Roles for Oral SERD Therapy in the Treatment of ER+/HER2– Breast CancerAna C. Garrido-Castro, MD; Pedram Razavi, MD, PhDView moreMultimediaExpert Roundtable and Panel Discussions: Current and Future Landscape of TNBCAditya Bardia, MD, MPH, FASCO; Erika P. Hamilton, MD; Tiffany A. Traina, MD, FASCOView moreAudioPractical Considerations and Future Directions for New Treatment Strategies in SCLCRahul Gosain, MD, MBA; Rohit Gosain, MD; Misty D. Shields, MD, PhDView moreAudioNavigating Treatment Gaps in SCLC: Relapse, Resistance, and Need for New OptionsRahul Gosain, MD, MBA; Rohit Gosain, MD; Giannis Mountzios ΜD, PhDView moreVideoMedical Crossfire® in Adjunctive Testing: Charting a New Course in Prostate Cancer Risk AssessmentJason Hafron, MD; Aaron D. Berger, MD; Arpeet Shah, MDView moreMultimediaImaging Matters: Decoding PSMA PET for Better Decision-MakingJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Scott T. Tagawa, MD, MS, FACP, FASCOView moreMultimediaWorking Together: Overcoming Barriers to Optimize Outcomes in Patients Treated With Radioligand Therapy Through Multidisciplinary CareJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Nerina McDonald, MSPAS, PA-C; Scott T. Tagawa, MD, MS, FACP, FASCOView moreMultimediaBURST CME™ Resource Center: Integrating Novel PSMA-Directed Radioligand Approaches for Diagnosis and Management of Prostate CancerJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Nerina McDonald, MSPAS, PA-C; Scott T. Tagawa, MD, MS, FACP, FASCOView moreMultimediaReady for Radioligand Therapy? Patient Selection and Sequencing SimplifiedJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Scott T. Tagawa, MD, MS, FACP, FASCOView moreMultimediaRadioligand Therapy 101: The Science Behind the StrategyJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Scott T. Tagawa, MD, MS, FACP, FASCOView moreVideo Advances in Managing EGFR-Mutant NSCLC: Applying Evidence Across the Disease ContinuumTina Cascone, MD, PhD; Christina Baik, MD, MPH; David Planchard, MD, PhDView moreMultimediaCommunity Practice Connections™: Enhancing Melanoma Outcomes With Intratumoral Oncolytic Immunotherapy–Strategies for the Multidisciplinary TeamYana G. Najjar, MD; Sapna Patel, MDView moreVideoA New Era of Targeted Therapy for Advanced NSCLC: Exploring Future Directions for Bispecific Antibodies and ADCsSandip Patel, MD, FASCO; Myung-Ju Ahn, MD; Giannis Mountzios, MD, MSc, PhD; Zofia Piotrowska, MD, MHSView moreVideoNavigating Advances in Neovascular Retinal Disease: Translating Evidence to Practice in AMD, DME, and RVOSriniVas R. Sadda, MD, FARVO; Mark R. Barakat, MD, FASRS; David A. Eichenbaum, MD, FASRSView moreVideoEnhancing Prostate Cancer Outcomes – The Role of PSMA and Targeted Treatment StrategiesAna Kiess, MD, PhD; Erin Grady, MD, CCD, FACNM, FSNMMI; Himanshu Nagar, MD, MS; Scott T. Tagawa, MD, MS, FASCO, FACPView moreVideo(CME Track) Antibody–Drug Conjugates in Oncology: The Essentials of AE Management for Better Patient OutcomesMichelle L. Taylor, ANP-BC; Emely Alfaro, DNP, RN, CNS, OCN; Paige Griffith, CRNP; Beth Sandy, MSN, CRNP, FAPOView more Advertisement Advertisement Trending on OncLive1FDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AML2FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma3FDA Grants Breakthrough Therapy Designation to Emi-Le for Adenoid Cystic Carcinoma4AUA and SUO Amend Advanced Prostate Cancer Guideline5Dr McCann on the FDA Approval of Vepdegestrant for ESR1-Mutated, ER+ Advanced Breast Cancer